Analytical Procedure Lifecycle Management - ECA Analytical QC Group and USP Validation and Verification Expert Panel Workshop

Analytical Procedure Lifecycle Management - ECA Analytical QC Group and USP Validation and Verification Expert Panel Workshop

Vienna, Austria

Course No 16193


Costs

Non-ECA Members: EUR 1790,--
ECA Members: EUR 1590,--
EU GMP Inspectorates: EUR 895,--
APIC Members: EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Speakers from the Validation & Verification Expert Panel at United States Pharmacopeia (USP):
Kimber Barnett, Pfizer
Dr Christopher Burgess, Burgess Analytical Consultancy Limited
Dr Joachim Ermer, Sanofi
Phil Nethercote, Former GSK
Jane Weitzel, Consultant

Speakers from the ECA Analytical QC Group:
Silviya Dimitrova, Actavis, a TEVA Company
Dr Gerd Jilge, Boehringer Ingelheim Pharma GmbH & Co. KG
Margarita Sabater, Dako Denmark A/S, an Agilent Technologies Company

Objectives

The assurance of ‘fitness for purpose’ of analytical procedures is a critical part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures and has published articles and a proposal for a new General Chapter <1220> aligned with the principles of US FDA and EU Annex 15 guidance on process validation.

In November 2016, ECA held a joint workshop with USP in Prague to discuss developments. In addition, ICH have instigated a revision workplan for Q2(R1) on Analytical Method Validation scheduled for completion by 2019/2020. Also the new ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Step 1 Core guideline, June 2017, provides further support for the analytical procedure lifecycle and preparing the way for performance based procedures.

In 2017, the board of the ECA’s Analytical Quality Control Group (AQCG) decided to
support the lifecycle approach for analytical procedures by drafting a new Guideline on ‘Analytical Procedure Lifecyle Management' (APLM).

This workshop conference will launch this draft guideline and actively discuss and review it as well as provide inputs for the finalized version 1. In addition, there will be an opportunity to discuss and generate input for the ICH Q2(R1) revision process. The speakers will be from both the ECA board and members of the USP’s Validation and Verification of Analytical Procedures Expert Panel.

Conference presentations, case studies and workshop discussions will help participants learn more about the current thinking on lifecycle management of analytical procedures and provide a forum for discussing how to move forward with the transition to and implementation of the lifecycle approach.

This meeting features 4 specifically designed interactive workshops on:

  • Analytical Target Profiles (ATPs)
  • Using Analytical Quality by Design methodology (AQbD) to deliver an ATP
  • Designing a Procedure Performance Qualification (PPQ) protocol to confirm the ATP
  • Designing a Procedure Verification strategy to confirm a state of control

Target Group

The assurance of ‘fitness for purpose’ of analytical procedures is a critical part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel
has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures and has published articles and a proposal for a new General Chapter <1220> aligned with the principles of US FDA and EU Annex 15 guidance on process validation.

In November 2016, ECA held a joint workshop with USP in Prague to discuss developments. In addition, ICH have instigated a revision workplan for Q2(R1) on Analytical Method Validation scheduled for completion by 2019/2020. Also the new ICH Q12: Technical and
Regulatory Considerations for Pharmaceutical Product Lifecycle Management Step 1 Core guideline, June 2017, provides further support for the analytical procedure lifecycle and
preparing the way for performance based procedures.

In 2017, the board of the ECA’s Analytical Quality Control Group (AQCG) decided to
support the lifecycle approach for analytical procedures by drafting a new Guideline on ‘Analytical Procedure Lifecyle Management' (APLM).

This workshop conference will launch this draft guideline and actively discuss and review it as well as provide inputs for the finalized version 1. In addition, there will be an opportunity to discuss and generate input for the ICH Q2(R1) revision process. The speakers will be from both the ECA board and members of the USP’s Validation and Verification of Analytical Procedures Expert Panel.

Conference presentations, case studies and workshop discussions will help participants learn more about the current thinking on lifecycle management of analytical procedures and provide a forum for discussing how to move forward with the transition to and implementation of the lifecycle approach.

This meeting features 4 specifically designed interactive workshops on:
Analytical Target Profiles (ATPs)
Using Analytical Quality by Design methodology (AQbD) to deliver an ATP
Designing a Procedure Performance Qualification (PPQ) protocol to confirm the ATP
Designing a Procedure Verification strategy to confirm a state of control

Programme

Introduction to the ECA Foundation and Academy
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Overview of the Workshop
Limitations of the current ICH Q2(R1) & USP General Chapters
Principles of Analytical Procedure Lifecycle Management (APLM)
Importance of adopting an APLM approach in the context of data integrity governance
Workshop intent and process
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Overview of the new APLM Guideline
ECA Guidelines; intent and applications
APLM process overview
Regulatory background
Content of new guideline
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Quality by Design; Application to Analytical Procedures
History and background to the initiative to apply QbD principles to analytical procedures
Advantages
Key elements of this approach
Phil Nethercote (USP V&V Expert Panel)

Development of an ATP
Kimber Barnett (USP V&V Expert Panel)

The importance of Target Measurement Uncertainty in an ATP
Target measurement uncertainty (TMU) is the maximum value for the uncertainty
associated with a reportable value in order for it to be fit for purpose. It is one of the
key components in the Lifecycle approach to analytical procedures
TMU helps define the analytical target profile (ATP)
TMU is required to determine the probability stated in a decision rule
TMU is a key performance criterion for analytical procedure performance throughout its life, from development through qualification and continued verification of performance
Jane Weitzel (USP V&V Expert Panel)

Workshop 1 on ATPs
Moderators: Kimber Barnett & Jane Weitzel (USP V&V Expert Panel)

Defining an Analytical Control Strategy
Definition of an ACS
Identification of the analytical procedure variables that impact the ATP based on Risk Management
Key elements of this approach
Margarita Sabater (ECA AQCG Board)

Workshop 2 on AQbD to deliver an ATP (Stage 1)
Moderators: Phil Nethercote (USP V&V Expert Panel) & Margarita Sabater (ECA AQCG Board)

Panel Q&A and Review of Day 1

ICH Q2A Revision Process; Aims and Objectives

  • A general approach for the validation of all relevant analytical procures
  • Discussion on the revision of the terminology of validation parameters
  • Definition of a “variability” of an analytical procedure
  • Implementation into the process of the “Analytical Target Profile” and the Life cycle process
Dr Gerd Jilge, (ECA AQCG Board)

Stage 2: Procedure Performance Qualification (PPQ)
Alignments, differences and advantages to traditional validation
General and procedure-specific performance attributes
Experimental confirmation in stage 2 or reference to stage 1?
Precision of the reportable value and replication strategy
Dr Joachim Ermer, (USP V&V Expert Panel)

Workshop 3
Designing a Procedure Performance Qualification (PPQ) protocol to confirm the ATP

Moderators: Dr Gerd Jilge, (ECA AQCG Board) & Dr Joachim Ermer, (USP V&V Expert Panel)

On going Performance Verification; Stage 3 (Principles & Approaches)
Analytical Procedures as processes
Process stability and capability
Requirements for routine process monitoring of analytical procedures
Quality Metrics
Dr Christopher Burgess, Chairman of the ECA AQCG Board

On going Performance Verification; Stage 3 (Analytical trending to ensure a state of control)
What to trend and what not to trend
Trending as part of the analytical control strategy and confirmation of the ATP
Are we trying to control means or individuals?
Overview of trending tools for discrete and variable data
Silviya Dimitrova (ECA AQCG Board)

Workshop 4
Designing a Procedure Verification Strategy to confirm a State of Control

Defining critical analytical procedure steps
Specification limits versus analytical trend limits
Selecting the right statistical tools for the job
Evaluating and interpreting trend data
Dr Christopher Burgess and Silviya Dimitrova (ECA AQCG Board)

Final Panel Discussion - “The Way Forward”

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